The World Health Organization (WHO) announces that the Saudi Food and Drug Authority (SFDA), the National Regulatory Authority (NRA) of Saudi Arabia has achieved maturity level four (ML4) for medicines and vaccines regulation, the highest level in WHO’s classification of regulatory authorities for medical products according to the Global Benchmarking Tool (GBT) signifying that SFDA is operating at an advanced level of performance with continuous improvement. 

Regulation of medical products is extremely important for all health systems and for access to quality vaccines, medicines and other health products. In addition to ensuring the quality, safety and efficacy of medical products, regulatory authorities that function well also perform critical activities such as timely authorization of medical products and safety monitoring.

SFDA Legacy

In 2003, the establishment of SFDA marked it as the exclusive agency responsible for regulating all medical products. And in November 2022, a WHO-led team of international regulators from five WHO regions formally benchmarked SFDA for medicines and vaccines, working closely with the WHO Regional Office for the Eastern Mediterranean. SFDA has achieved ML4, working closely with WHO to implement the recommendations made by its team of international regulatory experts.   

Moreover, This achievement by SFDA represents a significant milestone for Saudi Arabia and the region as SFDA becomes the first in the Eastern Mediterranean and the third one worldwide to reach ML4 based on WHO benchmarking exercise,” said Dr Yukiko Nakatani, Assistant Director-General for Access to Medicines and Health Products. Also his achievement reaffirms the long-standing collaboration between the WHO and the Government of Saudi Arabia towards the targets of universal health coverage and sustainable development goals, by ensuring and enhancing access to quality assured, safe, and effective medical products.

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“Resilient health systems in every setting cannot be discussed, planned, or implemented without applying quality and safety measures. Saudi Arabia and the WHO have a long history of collaboration, and this recent achievement by SFDA is a significant milestone on the road to achieving quality healthcare. This is the highest level in WHO’s classification of regulatory authorities for medical products. We look forward to further initiatives to ensure quality healthcare services for everyone. Working together to achieve universal health coverage and health for all by all,” says Dr Ahmed Al-Mandhari, WHO Regional Director.

What are the benefits for ML3 and ML4 countries?

Furthermore, Countries at ML3 and ML4 levels are eligible to attain WHO-listed authority (WLA) status. This scheme has been in operation since March 2022 and designates regulatory authorities that WHO and other regulatory bodies may use as a reference when making decisions about the approval of medical products.